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Immunotherapy

Bempegaldesleukin for Cancer (PIVOT-10 Trial)

Phase 2
Waitlist Available
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor assessments were performed at baseline and every 9 weeks from cycle 1 day 1 for the first 12 months, and then every 12 weeks as indicated in the schedule of events, up to approximately 27 months
Awards & highlights

PIVOT-10 Trial Summary

This study is evaluating whether a drug called NKTR-214 can help treat cancer.

Eligible Conditions
  • Cancer
  • Bladder Cancer

PIVOT-10 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor assessments were performed at baseline and every 9 weeks from cycle 1 day 1 for the first 12 months, and then every 12 weeks as indicated in the schedule of events, up to approximately 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessments were performed at baseline and every 9 weeks from cycle 1 day 1 for the first 12 months, and then every 12 weeks as indicated in the schedule of events, up to approximately 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
Secondary outcome measures
Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients
+1 more

Side effects data

From 2022 Phase 2 trial • 192 Patients • NCT03785925
44%
Pyrexia
31%
Fatigue
31%
Decreased appetite
30%
Anaemia
30%
Diarrhoea
29%
Nausea
23%
Constipation
23%
Pruritus
21%
Pruritus generalised
21%
Urinary tract infection
19%
Vomiting
19%
Arthralgia
19%
Asthenia
17%
Oedema peripheral
16%
Haematuria
15%
Hypothyroidism
14%
Chills
14%
Eosinophilia
13%
Blood creatinine increased
13%
Influenza like illness
12%
Dizziness
12%
Hypotension
12%
Back pain
11%
Cough
11%
Rash
10%
Dyspnoea
10%
Headache
9%
Hyperthyroidism
9%
Rash maculo-papular
8%
Abdominal pain
8%
Rash generalised
8%
Gamma-glutamyltransferase increased
8%
Insomnia
7%
Musculoskeletal pain
7%
Weight decreased
7%
Dry skin
7%
Hyponatraemia
7%
Pain in extremity
6%
Blood alkaline phosphatase increased
6%
Myalgia
6%
Infusion related reaction
6%
Dry mouth
6%
Amylase increased
6%
Aspartate aminotransferase increased
6%
Hypertension
5%
Acute kidney injury
5%
Face oedema
5%
Alanine aminotransferase increased
5%
Fall
2%
Pulmonary embolism
2%
Pneumonia
2%
Urosepsis
2%
Corona virus infection
1%
Hepatic failure
1%
Ileus
1%
Nephritis
1%
Pyelonephritis acute
1%
Bone pain
1%
Confusional state
1%
Cholecystitis
1%
Pancreatitis
1%
Hydronephrosis
1%
Female genital tract fistula
1%
Pyelonephritis chronic
1%
Obstruction gastric
1%
Delirium
1%
Large intestinal obstruction
1%
Intestinal obstruction
1%
Diverticulum intestinal
1%
Inguinal hernia
1%
Intestinal perforation
1%
Pharyngitis
1%
Pyelonephritis
1%
Urinary tract infection enterococcal
1%
Pancreatic carcinoma metastatic
1%
Atrial fibrillation
1%
Cardiac failure
1%
Renal abscess
1%
Upper respiratory tract infection
1%
Vascular device infection
1%
Bladder neck obstruction
1%
General physical health deterioration
1%
Sepsis
1%
Spinal cord infection
1%
Rectal haemorrhage
1%
Retroperitoneal haemorrhage
1%
Myocarditis
1%
Deep vein thrombosis
1%
Peripheral ischaemia
1%
Dehydration
1%
Cerebrovascular accident
1%
Bacterial sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Herpes zoster
1%
Lung infection
1%
Peritonitis
1%
Chronic kidney disease
1%
Kidney congestion
1%
Renal failure
1%
Urinary retention
1%
Urinary tract discomfort
1%
Urinary tract obstruction
1%
Sudden death
1%
Musculoskeletal chest pain
1%
Pathological fracture
1%
Polymyalgia rheumatica
1%
Acute myocardial infarction
1%
Cardio-respiratory arrest
1%
Peripheral arterial occlusive disease
1%
Peripheral artery thrombosis
1%
Thrombophlebitis superficial
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Type 2 diabetes mellitus
1%
Febrile neutropenia
1%
Haemorrhagic anaemia
1%
Cerebral infarction
1%
Cerebral microembolism
1%
Lung disorder
1%
Cervical vertebral fracture
1%
Lumbar vertebral fracture
1%
Procedural pain
1%
Breast cancer
1%
Malignant melanoma in situ
1%
Perineal pain
1%
Scrotal pain
1%
Cutaneous vasculitis
1%
Stevens-Johnson syndrome
1%
Hypophysitis
1%
Drug hypersensitivity
1%
Device occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination of Bempegaldesleukin (NKTR-214) + Nivolumab

PIVOT-10 Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimental Treatment2 Interventions
Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempegaldesleukin
2020
Completed Phase 3
~380
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,150 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,840 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,209 Previous Clinical Trials
489,272 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
2019. "A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03785925.
~32 spots leftby Apr 2025
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